MAUDE Adverse Event Report: EDWARDS LIFESCIENCES FEM-FLEX II FEMORAL ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number FEMII020A

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2021

Event Type  malfunction  

Manufacturer Narrative

Pre-decontamination evaluation: as received, one femii020a cannula with introducer.As received, the connector end was damaged.Unknown contamination were found along the wire-reinforced area of the cannula and the non-wired section that appears to be traces of blood.The product evaluation is still pending.The device was returned to edwards for evaluation.A supplemental mdr will be submitted upon completion of the product evaluation that has yet to begin.The cause of the event cannot be determined at this time.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported that the connector of femii020a femoral arterial cannula was found cracked and chipped when the red cap was removed after cannulation during use.The device was connect to the circuit successfully so the cannula was used after priming.There were no patient complications occurred.The cannula was inspected prior to use with the red cap on, but abnormality including fragments were not observed then.The patient status was reported as recovered.The fragment was not found.The cannula was stored flat in three layers at the hospital.The customer commented that if there was any noticeable damage in the package it would not have been used, therefore it is assumed to be no noticeable damage in the package.

Manufacturer Narrative

Added information to h3 and h6.H3.Device evaluation: customer complaint of connector of femii020a femoral arterial cannula was found cracked and chipped were confirmed.As received, dilator was inserted into the cannula.Device was returned with visible traces of blood.Cannula was observed to have two kinks along the cannula body at approximately 2.2 inch and 2.9 inches from the distal tip.Dilator was removed from the cannula with difficulty and met resistance when pushed through the kinked cannula.A crack approximately 1 inch long was observed on the barb connector with a broken off section at the proximal end.Broken connector fragment was not returned.No other visual damage, contamination, or other abnormalities were found to the cannula and dilator.Photos attached by complaint handler appeared consistent with lab findings.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections: d4 (expiration date), h4, and h6 (component codes, type of investigation, investigation findings, and investigation conclusions).The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Although the reported event was confirmed, the investigation could not conclusively determine the root cause.The root cause remains inconclusive.

• Brand Name: FEM-FLEX II FEMORAL ARTERIAL CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 13082195
• MDR Text Key: 282937901
• Report Number: 2015691-2021-07041
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2023
• Device Model Number: FEMII020A
• Device Lot Number: 63369201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 01/11/2022; 02/28/2022
• Supplement Dates FDA Received: 02/04/2022; 02/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1